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Gainor Medical U.S.A., Inc.

Country not established

Devices
2

What Gainor Medical U.S.A., Inc. makes

Gainor Medical U.S.A., Inc. manufactures surgical instruments, including the SURESHARP line of precision blades and the SUREWING line of retractors designed for surgical procedures.

These devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. The company is based in the United States.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Suresharp Ref K950159

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Surewing Ref K944824

    Active Regimes: 510(k) Registry: 510(k) Class:II

Frequently asked questions

How many devices does Gainor Medical U.S.A., Inc. have in the registry?

The registry currently lists 2 devices for Gainor Medical U.S.A., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gainor Medical U.S.A., Inc.'s devices?

Among its 2 most recently registered devices, Gainor Medical U.S.A., Inc. has devices listed in FDA 510(k) (2 devices).

What risk classes do Gainor Medical U.S.A., Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Gainor Medical U.S.A., Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Gainor Medical U.S.A., Inc. in the registry?

The most recently registered devices listed for Gainor Medical U.S.A., Inc. include SURESHARP and SUREWING.

Generated automatically from registry data and not verified by a human reviewer.